Novartis COPD drug delayed

The US Food and Drug Administration (FDA) has pushed back making a decision on the marketing application for Novartis' QAB149 (indacaterol) for chronic obstructive pulmonary disease (COPD) by three months.

Novartis said the FDA has not asked for additional data from the company, but needs the extra time to review data that has already been submitted. The agency now expects to take action on the application by July 2011.

"This three-month extension reflects discussion at the advisory committee based on the comprehensive clinical programme resulting in a large amount of data to be reviewed," said Trevor Mundel, global head of development at Novartis Pharma AG.

The FDA's Pulmonary-Allergy Drugs Advisory Committee, acting on a request from the FDA to evaluate the data for lower doses of QAB149, recently voted 13 to four in favour of recommending approval of a 75mcg dose, but 12 to five against recommending approval of a 150mcg dose.

The committee members deemed the lower dose as effective as the higher one and determined that the data showed that both doses are safe.

The advisory committee made its recommendations after reviewing five phase III clinical trials in which the efficacy of QAB149 at 75 and 150mcg was studied in a total of 1,282 COPD patients. The data showed that both doses significantly improved lung function compared to placebo, beginning five minutes after the first dose and lasting for 24 hours.

QAB149 was submitted for US regulatory approval in December 2008. In late 2009, the FDA issued a complete response letter declining to approve the drug until Novartis provided additional information on the proposed dosing.

Novartis is seeking US approval of the once-daily long-term maintenance bronchodilator treatment of airflow obstruction in patients with COPD including chronic bronchitis and/or emphysema. The product is already approved in dozens of countries around the world under the brandname Onbrez Breezhaler.